WO2017031476A3 - Purification of fkpa and uses thereof for producing recombinant polypeptides - Google Patents

Purification of fkpa and uses thereof for producing recombinant polypeptides Download PDF

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Publication number
WO2017031476A3
WO2017031476A3 PCT/US2016/047912 US2016047912W WO2017031476A3 WO 2017031476 A3 WO2017031476 A3 WO 2017031476A3 US 2016047912 W US2016047912 W US 2016047912W WO 2017031476 A3 WO2017031476 A3 WO 2017031476A3
Authority
WO
WIPO (PCT)
Prior art keywords
fkpa
polypeptides
methods
purification
multispecific antibodies
Prior art date
Application number
PCT/US2016/047912
Other languages
French (fr)
Other versions
WO2017031476A2 (en
Inventor
Chris B. FONG
Asif Ladiwala
Patrick A. MCKAY
Original Assignee
Genentech, Inc.
F. Hoffmann-La Roche Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to MX2018002068A priority Critical patent/MX2018002068A/en
Priority to EP16758343.4A priority patent/EP3337819B1/en
Priority to BR112018003127A priority patent/BR112018003127A2/en
Priority to CN201680061356.3A priority patent/CN108473558A/en
Application filed by Genentech, Inc., F. Hoffmann-La Roche Ag filed Critical Genentech, Inc.
Priority to AU2016308383A priority patent/AU2016308383A1/en
Priority to CA2995385A priority patent/CA2995385A1/en
Priority to JP2018509536A priority patent/JP7091238B2/en
Priority to KR1020187007920A priority patent/KR20180048731A/en
Publication of WO2017031476A2 publication Critical patent/WO2017031476A2/en
Publication of WO2017031476A3 publication Critical patent/WO2017031476A3/en
Priority to IL257400A priority patent/IL257400A/en
Priority to US15/932,222 priority patent/US20180327446A1/en
Priority to HK19101736.6A priority patent/HK1259368A1/en
Priority to IL288205A priority patent/IL288205A/en
Priority to JP2022003518A priority patent/JP2022062046A/en

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/24—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
    • C07K14/245—Escherichia (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria
    • C07K16/1228—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
    • C07K16/1232—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia from Escherichia (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/90—Isomerases (5.)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/563—Immunoassay; Biospecific binding assay; Materials therefor involving antibody fragments
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y502/00—Cis-trans-isomerases (5.2)
    • C12Y502/01—Cis-trans-Isomerases (5.2.1)
    • C12Y502/01008—Peptidylprolyl isomerase (5.2.1.8), i.e. cyclophilin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/99—Isomerases (5.)

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

The present invention provides methods for producing FKBP-type peptidyl-prolyl cis-trans isomerase (FkpA) polypeptides at very high levels of purity. Also provided are ultrapure FkpA and methods of using same, e.g., for use in immunoassays to show removal of FkpA from biologies produced in bacteria. In addition, the present invention provides methods of purifying polypeptides (e.g., multispecific antibodies) produced in bacteria overexpressing one or more chaperones. The methods include affinity chromatography, mixed-mode chromatography and hydrophobic interaction chromatography. In some aspects, the invention provides compositions of polypeptides (e.g., multispecific antibodies) that are essentially free of product-specific impurities.
PCT/US2016/047912 2015-08-20 2016-08-19 Purification of fkpa and uses thereof for producing recombinant polypeptides WO2017031476A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
CA2995385A CA2995385A1 (en) 2015-08-20 2016-08-19 Purification of fkpa and uses thereof for producing recombinant polypeptides
BR112018003127A BR112018003127A2 (en) 2015-08-20 2016-08-19 fkpa purification and uses thereof to produce recombinant polypeptides
CN201680061356.3A CN108473558A (en) 2015-08-20 2016-08-19 The purifying of FKPA and its purposes for producing recombinant polypeptide
KR1020187007920A KR20180048731A (en) 2015-08-20 2016-08-19 Purification of FKPA to produce recombinant polypeptides and uses thereof
AU2016308383A AU2016308383A1 (en) 2015-08-20 2016-08-19 Purification of FKPA and uses thereof for producing recombinant polypeptides
EP16758343.4A EP3337819B1 (en) 2015-08-20 2016-08-19 Method of purifying for producing recombinant polypeptides using fkpa
JP2018509536A JP7091238B2 (en) 2015-08-20 2016-08-19 Purification of FKPA and its use for the production of recombinant polypeptides
MX2018002068A MX2018002068A (en) 2015-08-20 2016-08-19 Purification of fkpa and uses thereof for producing recombinant polypeptides.
IL257400A IL257400A (en) 2015-08-20 2018-02-07 Purification of fkpa and uses thereof for producing recombinant polypeptides
US15/932,222 US20180327446A1 (en) 2015-08-20 2018-02-16 Purification of fkpa and uses thereof for producing recombinant polypeptides
HK19101736.6A HK1259368A1 (en) 2015-08-20 2019-01-31 Purification of fkpa and uses thereof for producing recombinant polypeptides
IL288205A IL288205A (en) 2015-08-20 2021-11-17 Purification of fkpa and uses thereof for producing recombinant polypeptides
JP2022003518A JP2022062046A (en) 2015-08-20 2022-01-13 Purification of fkpa and uses thereof for producing recombinant polypeptides

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201562207910P 2015-08-20 2015-08-20
US201562207908P 2015-08-20 2015-08-20
US62/207,908 2015-08-20
US62/207,910 2015-08-20
US201562210378P 2015-08-26 2015-08-26
US62/210,378 2015-08-26

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/932,222 Continuation US20180327446A1 (en) 2015-08-20 2018-02-16 Purification of fkpa and uses thereof for producing recombinant polypeptides

Publications (2)

Publication Number Publication Date
WO2017031476A2 WO2017031476A2 (en) 2017-02-23
WO2017031476A3 true WO2017031476A3 (en) 2017-04-13

Family

ID=58052052

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/047912 WO2017031476A2 (en) 2015-08-20 2016-08-19 Purification of fkpa and uses thereof for producing recombinant polypeptides

Country Status (13)

Country Link
US (1) US20180327446A1 (en)
EP (1) EP3337819B1 (en)
JP (2) JP7091238B2 (en)
KR (1) KR20180048731A (en)
CN (1) CN108473558A (en)
AU (1) AU2016308383A1 (en)
BR (1) BR112018003127A2 (en)
CA (1) CA2995385A1 (en)
HK (1) HK1259368A1 (en)
IL (2) IL257400A (en)
MX (1) MX2018002068A (en)
TW (1) TW201718623A (en)
WO (1) WO2017031476A2 (en)

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US10704021B2 (en) 2012-03-15 2020-07-07 Flodesign Sonics, Inc. Acoustic perfusion devices
US9458450B2 (en) 2012-03-15 2016-10-04 Flodesign Sonics, Inc. Acoustophoretic separation technology using multi-dimensional standing waves
EP3092049A1 (en) 2014-01-08 2016-11-16 Flodesign Sonics Inc. Acoustophoresis device with dual acoustophoretic chamber
US11377651B2 (en) 2016-10-19 2022-07-05 Flodesign Sonics, Inc. Cell therapy processes utilizing acoustophoresis
US11708572B2 (en) 2015-04-29 2023-07-25 Flodesign Sonics, Inc. Acoustic cell separation techniques and processes
US11474085B2 (en) 2015-07-28 2022-10-18 Flodesign Sonics, Inc. Expanded bed affinity selection
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US11214789B2 (en) 2016-05-03 2022-01-04 Flodesign Sonics, Inc. Concentration and washing of particles with acoustics
US11085035B2 (en) 2016-05-03 2021-08-10 Flodesign Sonics, Inc. Therapeutic cell washing, concentration, and separation utilizing acoustophoresis
WO2019118921A1 (en) 2017-12-14 2019-06-20 Flodesign Sonics, Inc. Acoustic transducer drive and controller
US11518781B2 (en) * 2017-12-29 2022-12-06 Hoffmann-La Roche Inc. Process for providing PEGylated protein composition
BR112020015603A2 (en) * 2018-02-27 2021-01-05 Pfizer Inc. ANTIBODY PURIFICATION
CA3094644A1 (en) * 2018-03-21 2019-09-26 Baxalta Incorporated Separation of vwf and vwf propeptide by chromatographic methods
EP3774926A1 (en) 2018-04-05 2021-02-17 Bio-Rad ABD Serotec GmbH Display systems for proteins of interest
CN112955220A (en) * 2018-09-25 2021-06-11 伊克诺斯科学公司 Antibody quantification in biological samples
CN114409798A (en) * 2019-02-14 2022-04-29 美勒斯公司 Preparation of a composition comprising two or more antibodies
JP2022525775A (en) 2019-03-18 2022-05-19 バイオ－ラッド エービーディー セロテック ゲーエムベーハー Protection of SpyTag-containing periplasmic fusion proteins from protease TSP and OMPT degradation
WO2020227144A1 (en) * 2019-05-03 2020-11-12 Genentech, Inc. Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
AU2020405026A1 (en) * 2019-12-20 2022-06-16 Merck Sharp & Dohme Llc Purified compositions of enteroviruses and methods of purification with glutathione affinity chromatography
US20230357315A1 (en) * 2020-03-11 2023-11-09 Dr. Reddy's Laboratories Limited METHOD OF PURIFYING AN Fc-FUSION PROTEIN

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Also Published As

Publication number Publication date
HK1259368A1 (en) 2019-11-29
WO2017031476A2 (en) 2017-02-23
AU2016308383A1 (en) 2018-03-15
MX2018002068A (en) 2018-06-06
BR112018003127A2 (en) 2018-09-25
JP7091238B2 (en) 2022-06-27
EP3337819B1 (en) 2024-02-21
EP3337819A2 (en) 2018-06-27
US20180327446A1 (en) 2018-11-15
TW201718623A (en) 2017-06-01
JP2018533355A (en) 2018-11-15
CN108473558A (en) 2018-08-31
CA2995385A1 (en) 2017-02-23
IL257400A (en) 2018-04-30
KR20180048731A (en) 2018-05-10
EP3337819C0 (en) 2024-02-21
IL288205A (en) 2022-01-01
JP2022062046A (en) 2022-04-19

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